15 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Cios Spin
FDA 510(k)
FDA Class 2
·Radiology
VULCAN
FDA UDI
Smith & Nephew, Inc.·00885554010770·MTO KIT VULCAN GEN S. AFRICA /
Vessel Probe 20cm 2.5mm, thin wire green alu handle
FDA UDI
Geister Medizintechnik GmbH·04057034045916·Vessel Probe 20cm 2.5mm, thin wire
green ...
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319744246·Woodson Elevator 7" (18cm), double ended
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K1100540·Caddie, 8.5mm Screws
Surgical Direct
FDA UDI
Surgical Direct, Inc.·B382SD840362100540·3 1/2" McPherson Specialty Bipolar Forceps, Sil...
Dilator, Vascular, acc. Geister 20cm 2.5mm alu-handle GREEN
FDA UDI
Geister Medizintechnik GmbH·04057034045923·Dilator, Vascular, acc. Geister
20cm 2...
NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE
FDA 510(k)
FDA Class 2
·Neurology
GUTHRIE SHIELD BLUE LATEX EXAMINATION GLOVES, POWDERED WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
FEP
FDA UDI
Merit Medical Systems, Inc.·00884450000632·
BD BBL Sensi Disc Chloramphenicol- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 230733¿and 231274¿
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
ECHELON 60 ENDOPATH STAPLER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GDW·October 22, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 12, 2011
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 3, 2013
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015